FOR ADULTS WITH ACTIVE PsA

DEMONSTRATED JOINT SYMPTOM CONTROL IN ACTIVE PsA

ACR20 RESPONSE RATES OVER TIME

ACR20 response at Week 14 (primary endpoint) vs placebo*†‡:

75%

Seventy Five Percent
of patients receiving
SIMPONI ARIA® +/- MTX (181/241)
achieved ACR20 response (P<0.001)
versus icon

22%

Twenty Two Percent
of patients receiving placebo
+/- MTX (52/239)1-3

ACR20 response in patients receiving SIMPONI ARIA® + MTX was
similar to those receiving SIMPONI ARIA® without MTX1-4

ACR20 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

Rapid ACR20 response at Week 2*†‡:

46%

of patients receiving
SIMPONI ARIA® +/- MTX (110/241)
achieved ACR20 response
versus icon

8%

of patients receiving placebo
+/- MTX (18/239)1-3

ACR20 response at Week 24*†‡:

77%

of patients receiving
SIMPONI ARIA® +/- MTX (185/241) achieved ACR20 response
versus icon

24%

of patients receiving placebo +/- MTX (58/239)1-3

ACR20 responses at Week 2 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

ACR 20 response Rate Graph

WEEK 24 CROSSOVER

ACR20 response at Week 52§||¶:

77%

of patients receiving
SIMPONI ARIA® +/- MTX achieved ACR20 response
versus icon

77%

of patients receiving placebo +/- MTX who crossed over to SIMPONI ARIA® +/- MTX2,4
ACR20 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.
ACR20 response for patients receiving SIMPONI ARIA® + MTX was similar to those receiving SIMPONI ARIA® without MTX.

*The same patients may not have responded at each time point.

†ACR20 responses are based on imputed data using treatment failure, last observation carried forward for partially missing data, and nonresponder imputation for completely missing data.

‡In this ITT analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, IV, or intramuscular corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

§Treatment failure criteria were not applied after Week 24.

||At Week 24, all remaining patients in the placebo +/- MTX group began receiving SIMPONI ARIA® +/- MTX in a blinded manner. At Week 24, subjects in the SIMPONI ARIA® +/- MTX group received a placebo infusion to maintain the treatment blind, and then continued to receive SIMPONI ARIA® +/- MTX at Week 28 and q8w thereafter through Week 52.

After Week 24, selected sponsor personnel were unblinded to subject-level data, which may have affected results.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/‍kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/‍kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.1
ACR20=20% improvement in American College of Rheumatology criteria; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; ITT=intention-to-treat; IV=intravenous; MTX=methotrexate; PsA=psoriatic arthritis; q8w=every 8 weeks.
Back to Top

ACR50 RESPONSE RATES OVER TIME

ACR50 response at Week 14 vs placebo*†‡:

Major Secondary Endpoint

44%

Fourty Four Percent
of patients receiving
SIMPONI ARIA® +/- MTX (105/241)
achieved ACR50 response (P<0.001)
versus icon

6%

Six Percent
of patients receiving placebo
+/- MTX (15/239)1-3

ACR50 response at Week 2*†‡:

13%

of patients receiving
SIMPONI ARIA® +/- MTX (31/241) achieved ACR50 response
versus icon

0.4%

of patients receiving placebo +/- MTX (1/239)1-3

ACR50 response at Week 24*†‡:

54%

of patients receiving
SIMPONI ARIA® +/- MTX (130/241) achieved ACR50 response (P<0.001)
versus icon

6%

of patients receiving placebo +/- MTX (14/239)1-3
ACR50 responses at Week 2 were not adjusted for multiplicity. Therefore, statistical significance has not been established.
ACR 50 response Rate Graph

WEEK 24 CROSSOVER

ACR50 response at Week 52§||¶:

58%

of patients receiving
SIMPONI ARIA® +/- MTX achieved ACR50 response
versus icon

54%

of patients receiving placebo +/- MTX who crossed over to SIMPONI ARIA® +/- MTX2,4
ACR50 responses at Week 2 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*The same patients may not have responded at each time point.

†ACR50 response is based on imputed data using treatment failure, last observation carried forward (LOCF) for partially missing data, and nonresponder imputation (NRI) for completely missing data.

‡In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

§Treatment failure criteria were not applied after Week 24.

||At Week 24, all remaining patients in the placebo +/- MTX group began receiving SIMPONI ARIA® +/- MTX in a blinded manner. At Week 24, subjects in the SIMPONI ARIA® +/- MTX group received a placebo infusion to maintain the treatment blind, and then continued to receive SIMPONI ARIA® +/- MTX at Week 28 and q8w thereafter through Week 52.

After Week 24, selected sponsor personnel were unblinded to subject-level data, which may have affected results.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/‍kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/‍kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.1
ACR50=50% improvement in American College of Rheumatology criteria; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; MTX=methotrexate; PsA=psoriatic arthritis; q8w=every 8 weeks.
Back to Top

ACR70 RESPONSE RATES OVER TIME

ACR70 response at Week 14 vs placebo*†‡:

25%

Twenty Five Percent
of patients receiving
SIMPONI ARIA® +/- MTX (59/241)
achieved ACR70 response (P<0.001)
versus icon

2%

Two Percent
of patients receiving
placebo
+/- MTX (5/239)1-3

ACR70 response at Week 24*†:

33%

of patients receiving
SIMPONI ARIA® +/- MTX (79/241) achieved ACR70 response
versus icon

3%

of patients receiving
placebo +/- MTX (8/239)1-3
ACR 70 response Rate Graph

WEEK 24 CROSSOVER

ACR70 response at Week 52§||¶:

39%

of patients receiving
SIMPONI ARIA® +/- MTX achieved ACR70 response
versus icon

34%

of patients receiving placebo +/- MTX who crossed over to SIMPONI ARIA® +/- MTX2,4
ACR70 responses at Week 2 and Week 24 were not adjusted for multiplicity. Therefore, statistical significance has not been established.

*The same patients may not have responded at each time point.

†ACR70 response is based on imputed data using treatment failure, last observation carried forward (LOCF) for partially missing data, and nonresponder imputation (NRI) for completely missing data.

‡In this intention-to-treat (ITT) analysis, patients were considered to be nonresponders if they experienced any of the following: increased the dose of MTX or oral corticosteroids over baseline for PsA not as part of early escape; initiated treatment with DMARDs, systemic immunosuppressives, treatment with oral, intravenous (IV), or intramuscular (IM) corticosteroids, and/or biologics for PsA; met early escape criteria at Week 16 and started concomitant medication intervention; or discontinued treatment due to an unsatisfactory therapeutic effect.

§Treatment failure criteria were not applied after Week 24.

||At Week 24, all remaining patients in the placebo +/- MTX group began receiving SIMPONI ARIA® +/- MTX in a blinded manner. At Week 24, subjects in the SIMPONI ARIA® +/- MTX group received a placebo infusion to maintain the treatment blind, and then continued to receive SIMPONI ARIA® +/- MTX at Week 28 and q8w thereafter through Week 52.

After Week 24, selected sponsor personnel were unblinded to subject-level data, which may have affected results.

Study design: GO-VIBRANT was a global, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of SIMPONI ARIA® compared with placebo in 480 adult patients with active PsA. The target study population was biologic-naïve patients with active PsA for ≥6 months who met ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. Patients in this trial had a diagnosis of PsA for at least 6 months and had symptoms of active disease (≥5 swollen joints and ≥5 tender joints and a CRP level of ≥0.6 mg/dL). At Week 0, patients were randomized in a 1:1 ratio to 1 of 2 treatment groups. Patients were allowed to be treated with or without MTX. Patients in the placebo group (n=239) were randomized to receive IV placebo infusions at Weeks 0, 4, 12, and 20. Patients in the SIMPONI ARIA® group (n=241) were randomized to receive SIMPONI ARIA® 2 mg/‍kg infusions at Weeks 0, 4, and q8w thereafter through Week 52. Patients were to receive a placebo infusion at Week 24 to maintain the treatment blind. At Week 24, all patients switched to treatment with SIMPONI ARIA® 2 mg/‍kg and were to receive administrations at Weeks 24, 28, and q8w through Week 52. The primary endpoint was the percentage of patients achieving an ACR20 response at Week 14.1
ACR70=70% improvement in American College of Rheumatology criteria; CRP=C-reactive protein; DMARD=disease-modifying anti-rheumatic drug; MTX=methotrexate; PsA=psoriatic arthritis; q8w=every 8 weeks.
NEXT: View Inhibition of Radiographic Progression in PsA »

References: 1. Data on file. Johnson & Johnson. 2. SIMPONI ARIA® (golimumab) [Prescribing Information]. Horsham, PA: Johnson & Johnson. 3. Kavanaugh A, Husni ME, Harrison DD, et al. Safety and efficacy of intravenous golimumab in patients with active psoriatic arthritis: results through week twenty-four of the GO-VIBRANT study. Arthritis Rheumatol.
2017;69(11):2151-2161. doi: 10.1002/art.40226. 4. Husni ME, Kavanaugh A, Murphy F, et al. Efficacy and safety of intravenous golimumab through one year in patients with active psoriatic arthritis. Arthrit Care Res. 2006;45(6):885-889.